Six in hospital after French pain relief drug trial goes wrong

Six in hospital after French pain relief drug trial goes wrong

来源：未知 作者：杨酷 时间：2017-07-02 04:01:25

By Debora Mackenzie Six people have been hospitalised after a drug trial went terribly wrong at the Pontchaillou Hospital in Rennes in France. One has been declared brain-dead, and four others are in critical condition. Ninety participants in the trial have been asked to contact the hospital. According to preliminary reports, the trial was of a drug aimed at inhibiting the brain enzyme that degrades endogenous cannabinoids, chemicals produced naturally by the brain that resemble the active compounds in cannabis. The drug is being developed by Portuguese firm Bial. It was a “phase one” trial, in which a new drug that has been tested in animals is tested for the first time in humans. The idea is to make sure it is safe, and to measure its effects. Usually a range of relatively low doses are used in such trials. In a press conference on Friday afternoon, French health minister Marisol Touraine said the drug “does not contain cannabis or any derivative of cannabis.” Only people who had been given repeated doses of the drug were affected. Five of six men between the ages of 28 and 49 started developing the same neurological symptoms on 10 January, after receiving their first dose of the drug on 7 January. Gilles Edan, head of neuroscience at the hospital, said the sixth had no symptoms but was under observation. Three of the four in critical condition, however, will have permanent damage. All six got the same dose, while two additional people who received a harmless placebo drug at the same time were not affected. “It is definitely the product that is responsible.” said Edan (pictured above with Touraine). The tragedy resembles a similar event in Britain in 2006 in which six men were nearly killed by a drug aimed at modifying the immune system. It had seemed perfectly safe in animals. In humans, however, it unleashed a “cytokine storm”, an over-reaction of the immune system that can be fatal. An inquiry after the incident called for more care to be taken in Phase 1 trials. The brain naturally contains cannabinoids, which among other things provide a measure of pain relief. These endogenous cannabinoids, such as anandamide, are degraded by an enzyme called FAAH. Bial has been developing compounds that inhibit this enzyme in order to increase brain levels of cannabinoids, as an anti-depressant or a pain reliever. The trial in Rennes was being conducted by a company called Biotrial that specialises in clinical trials. On Friday afternoon the company’s international site was still asking visitors if they would like to volunteer in Rennes. The number for trial participants to contact the hospital is, in France, 02-9998-2447. Image credit: